EP0618818A1 - Sicherheitsspritze - Google Patents

Sicherheitsspritze

Info

Publication number
EP0618818A1
EP0618818A1 EP93901899A EP93901899A EP0618818A1 EP 0618818 A1 EP0618818 A1 EP 0618818A1 EP 93901899 A EP93901899 A EP 93901899A EP 93901899 A EP93901899 A EP 93901899A EP 0618818 A1 EP0618818 A1 EP 0618818A1
Authority
EP
European Patent Office
Prior art keywords
needle
plunger
barrel
deformable base
enlarged
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP93901899A
Other languages
English (en)
French (fr)
Other versions
EP0618818A4 (de
Inventor
William B. S. Pressly
Charles Arthur Vaughn Sr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SYRINGE DEVELOPMENT PARTNERS L.L.C.
Original Assignee
SYRINGE DEVELOPMENT PARTNERS PRESSLY WILLIAM B S LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SYRINGE DEVELOPMENT PARTNERS PRESSLY WILLIAM B S LLC filed Critical SYRINGE DEVELOPMENT PARTNERS PRESSLY WILLIAM B S LLC
Priority to EP98105451A priority Critical patent/EP0914837A3/de
Publication of EP0618818A1 publication Critical patent/EP0618818A1/de
Publication of EP0618818A4 publication Critical patent/EP0618818A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3223—Means impeding or disabling repositioning of used needles at the syringe nozzle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3223—Means impeding or disabling repositioning of used needles at the syringe nozzle
    • A61M2005/3224—Means to disalign the needle tip and syringe nozzle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/508—Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

Definitions

  • This invention relates generally to the art of syringes and more particularly to a syringe which reduces the likelihood of unintentional puncture or pricking of human skin.
  • the transmission of contagious diseases particularly those brought about exclusively by the co-mingling of human body fluids, has been of great technological interest.
  • One of the particular problems has been associated with the use and disposal of hypodermic syringes, particularly among healthcare professionals.
  • a hypodermic syringe having a barrel with a movable plunger therein to inject a fluid through a hollow needle thereof.
  • a hollow needle is housed in a passageway within a needle assembly.
  • a deformable base Positioned between sacrificial support means in the needle assembly and an internal wedged end of the barrel is a deformable base which forms a liquid tight seal with the barrel, at the needle end of the barrel.
  • the deformable base houses an enlarged head- of the needle which enlarged head is in contact with energy storage means within the passageway in the needle assembly.
  • the plunger has a rupturable boot thereon which is otherwise liquid impermeable for forcing a liquid rom the barrel upon movement of the plunger.
  • the rupturable boot Upon completion of an injection, the rupturable boot contacts the deformable base, and upon application of force at the plunger, moves such base downward, initially breaking the liquid tight seal between the deformable base and the barrel. Continued application of force causes sacrificial support means within the needle assembly to sever, permitting the deformable base to move the enlarged head of the needle downward until further movement of the enlarged head is blocked by the passageway in the needle assembly. With the enlarged needle head blocked by the passageway, continued force at the plunger causes the deformable base to move around the enlarged needle head. As the deformable base moves forward, the enlarged needle head begins to protrude from the deformable base and come into contact with a thin web on the rupturable boot of the plunger.
  • FIG. 1 Figure 3 of the drawings is an isolated view of the needle assembly of this invention.
  • Figure 3(a) is a cross-sectional view along line A-A of figure 3, illustrating sacrificial support means and a passageway in the needle assembly.
  • Figure 4 of the drawings is a side view of the deformable base.
  • Figure 4(a) is a cross-sectional view along line B-B of figure 4.
  • Figure 5 of the drawings is a side view of the energy storage means.
  • Figure 6 of the drawings is a side view of the needle or cannula.
  • Figure 7 of the drawings is a side view of the absorbent material.
  • Figure 8 of the drawings is a cross-sectional view of the rupturable boot.
  • Figure 8(a) is a view along line C-C of figure 8, showing a thin web of the rupturable boot.
  • Figure 9 of the drawings is a side view of a transparent barrel of this invention.
  • Figure 9(a) is an enlarged cross-sectional view of the encircled area of figure 9, illustrating a wedge in the needle end of the barrel
  • Figure 9(b) is a view along line D-D of figure 9, showing plunger mating on the operating end of the barrel and finger support means.
  • Figure 10 of the drawings is a side view of a plunger in accordance with this invention.
  • Figure 10(a) is a view along line E-E of figure 10, showing mating on the plunger for the rupturable boot and showing needle capturing means.
  • Figures 11, 12, and 13 of the drawings are cross-sectional subassembly views illustrating the assembly of the needle, base, barrel, needle assembly, absorbent means, and energy storage means.
  • Figure 14 of the drawings is a cross-sectional view of the plunger of this invention, showing assembly of the rupturable boot on the plunger.
  • Figure 14(a) is an enlarged view of the encircled area of figure 14, showing more clearly the rupturable boot assembled on the plunger.
  • Figure 15 of the drawings is a view of the completed assembly of the syringe
  • FIGS 16, 17, 18, 19, 20, 21, 22, and 23 of the drawings are cross-sectional views of the apparatus of this invention showing the sequence of operation, after the injection cycle.
  • Figure 24 of the drawings is a cross-sectional view of a plunger in a different embodiment of this invention.
  • Figure 24(a) is a view along line G-G of figure 24, showing a second embodiment of entrapment means for this invention.
  • Figure 25 of the drawings is a cross-sectional view similar to figure 24 showing the entrapment of a needle therein.
  • a syringe may be provided for normal operation but, which upon completion of normal operation and continued movement of a plunger, results in a triggering of the needle or cannula to project such needle harmlessly into the plunger of the syringe.
  • Figures 1 and 2 of the drawings illustrate the syringe 1 of this invention with the needle 3 illustrated in figure 1 in its normal pre-injection position.
  • Figure 2 of the drawings shows the net result of this invention wherein the needle 3 has been trapped and rendered harmless after the injection has taken place, and the plunger has been locked within the barrel of the syringe.
  • the syringe 1 in accordance with this invention has relatively few components, which along with their function, will now be described with reference to the drawings in sequence beginning with figure 1.
  • the syringe 1 has a barrel 5 and a plunger 7 mounted the ⁇ rein.
  • the needle 3 is contained within a needle assembly 9, which is fixed to barrel 5 by ultrasonic welding means or other permanent attaching means.
  • Needle 3 has an enlarged head 13 mounted within deformable base 11.
  • Enlarged head 13 has a wedge portion 15 and a circular flange portion 17.
  • the geometries of the flange portion and wedge portion of enlarged head 13 lock such enlarged head portion 13 within deformable base 11, while also creating a liquid tight seal between needle head 13 and deformable base 11.
  • Needle assembly 9 has contained therein energy storage means
  • Enlarged needle head 13 has a contacting portion 25 which contacts energy storage means 21.
  • Sacrificial support means 31 position deformable base 11 within needle assembly 9.
  • Plunger 7 has a hollow 41 therein and is terminated by a rupturable boot 43 which is fluid impermeable for movement of a fluid in barrel 5 during ordinary injection.
  • Rupturable boot 43 is illustrated as having been ruptured in figure 2.
  • plunger 7- has an enlarged compression section at thumb push 45 which, upon completion of a compression stroke, is locked within a mating head portion 47 of barrel 5.
  • Plunger 7 has needle capturing means 49 therein which is illustrated in figure 2 as preventing the release of needle 3 from plunger 7.
  • an absorption means 51 such as cotton, to collect any fluids which may drain from needle 3 after the capture thereof.
  • FIG. 3 of the drawings is an isolated view of the needle assembly 9 of this invention. Sacrificial support means 31 and passageway 23 are illustrated in partial phantom.
  • Figure 3(a) is a cross-sectional view along the line A-A of figure 3, further illustrating sacrificial support means 31 and passageway 23 within needle assembly 9.
  • Figure 4 of the drawings is a side view of deformable base 11.
  • a preferred material for base 11 is an elastomer.
  • counterbore 73 and thrubore 75 are provided for proper positioning of the needle in the deformable base.
  • Figure 4(a) is a cross-sectional view along the line B-B of figure 4 further illustrating deformable base 11.
  • Figure 5 of the drawings is a side view of the energy stomeans 21 illustrated as a spring.
  • Figure 6 of the drawings is a side view of needle 3 or cannula.
  • Contactor 25 circular flange 17 and enlarged head 13 with wedge portion 15 are illustrated.
  • Also illustrated in phantom is the hollow portion 16 of the needle.
  • Figure 7 shows a side view of absorption means 51 with mounting hole 77.
  • Figure 8 of the drawings is a cross-sectional view of the rupturable boot 43.
  • Figure 8(a) is a view along the line C-C of figure 8 further illustrating rupturable boot 43, with a thin web 79 to aid in the rupturing process.
  • the thickness of web 79 is selected to withstand normal dynamic pressures within syringe 1, as shown in figure 1, but allows relative ease in the puncturing of boot 43 by enlarged needle head 13, as shown in figure 6.
  • Figure 9 of the drawings is a side view of a transparent barrel 5 of this invention, illustrating a lOcc device.
  • Figure 9(a) is an enlarged cross-sectional view of the encircled area of figure 9 showing barrel wedge 71.
  • Figure 9(b) is a view along the line D-D of figure 9 of barrel 5.
  • Mating head portion 47 of barrel 5 is illustrated in phantom, while finger support flange 81 is shown as a full view looking towards the back of the syringe.
  • Figure 10 of the drawings is a side view of plunger 7 in accordance with this invention, with capturing means 49 illustrated in partial phantom therein.
  • Figure 10(a) is a view along the line E-E of figure 10 of plunger 7, further illustrating capturing means 49 within plunger 7.
  • the first assembly step is accomplished by inserting needle 3 into deformable base 11 preferably from the thrubore side. Once inserted, circular flange 17 is positioned into counterbore 73 which blocks needle movement in one direction, since thrubore 75, as shown in figure 4, is slightly smaller in diameter than flange 17. Needle wedge 15 expands thrubore 75, as seen in figure 4, creating a liquid tight seal between needle head 13 and base 11 as shown in figure 11, while also blocking needle movement in the opposite direction. With needle 3 blocked into base 11, assembly step 2 is next accomplished.
  • the subassembly in figure 11 is inserted into the wedged end of barrel 5.
  • barrel wedge 71 compresses base 11 circumferentially in the direction of needle head 13, and a liquid tight seal is produced between base 11 and barrel 5.
  • assembly step 3 is accomplished by first placing absorbent material 51 over passageway 23 in needle assembly 9, as shown in the subassembly of figure 13.
  • Energy storage means 21 is then inserted into passageway 23.
  • the preferred embodiment of energy storage means is a spring.
  • Needle assembly 9 is then fixed to barrel 5 by threading needle 3 through the center of spring 21 in passageway 23 and compressing spring 21 until needle assembly 9 is in a position where sacrificial support means 31 are firmly against base 11 and overlap 79 between needle assembly 9 and barrel 5 is created. During this assembly step significant energy is transferred to energy storage means 21. Permanent joining between needle assembly 9 and barrel 5 is accomplished by ultrasonic welding around the circumference at overlap 79, or other permanent attaching means.
  • figure 1 is a cross-sectional view of safety syringe 1.
  • safety syringe 1 operates as any conventional syringe.
  • the syringe is filled from an ampule in a normal manner, as standard procedure dictates. Once filled, the injection cycle is accomplished, again according to standard practice. At completion of the injection cycle, plunger 7 is just mating with base 11, as shown in figure 16, and all fluids, which can be, are expended from syringe 1. Before the syringe is released, or discarded, by the user, the needle retraction cycle should be accomplished.
  • syringe 1 is usually held between the index finger and the middle finger at support flange 81, with the thumb resting on thumb push 45, presumably the same as the syringe was held at completion of the injection cycle.
  • Plunger 7 is just mated with base 11 at rupturable boot 43, as shown in figure 16.
  • force is applied between finger support flange 81 and thumb push 45. This force is transmitted along plunger 7 to deformable base 11 and sacrificial support means 31. As the force increases sufficiently, the liquid tight seal between barrel 5 and deformable base 11 is broken, and sacrificial support means 31 begin to fracture.
  • enlarged needle head 13 is blocked by passageway 23, and continued force at plunger 7 causes deformable base 11 to deform and move around circular flange 17 on enlarged needle head 13. As deformable base 11 moves forward, enlarged needle head 13 begins to protrude from base 11 and come into contact with web 79 of rupturable boot
  • needle 3 at its enlarged head 13, contacts capturing means 49 which deforms to permit enlarged needle head 13 to pass through the constriction formed by capturing means 49.
  • FIG 23 where needle 3 is shown captured within hollow 41 of plunger 7.
  • plunger thumb push 45 has been locked within the mating section 47 of barrel 5.
  • fluids remaining in needle 3 flow within hollow 41, down the exterior side of passageway 23 to absorbent means 51 where the fluids are absorbed and prevented from being released from the interior of syringe 1.
  • An optional capturing means is illustrated in figure 24 wherein a plunger 61 has a constricted head portion 63 adjacent to a contacting portion 65.
  • FIG 25 is a view of plunger 61 taken along line G-G of figure 24 showing the constricted head portion 63.
  • Other capturing means may also by utilized.
  • this invention provides a novel syringe apparatus which is operable by a single hand and which upon completion of injection captures the utilized needle and renders such harmless within the plunger of the syringe.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP93901899A 1991-12-23 1992-12-22 Sicherheitsspritze. Withdrawn EP0618818A4 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP98105451A EP0914837A3 (de) 1991-12-23 1992-12-22 Sicherheitsspritze

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US813115 1991-12-23
US07/813,115 US5211629A (en) 1991-12-23 1991-12-23 Safety syringe
PCT/US1992/011167 WO1993012829A1 (en) 1991-12-23 1992-12-22 Safety syringe

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP98105451A Division EP0914837A3 (de) 1991-12-23 1992-12-22 Sicherheitsspritze

Publications (2)

Publication Number Publication Date
EP0618818A1 true EP0618818A1 (de) 1994-10-12
EP0618818A4 EP0618818A4 (de) 1995-05-24

Family

ID=25211493

Family Applications (2)

Application Number Title Priority Date Filing Date
EP98105451A Withdrawn EP0914837A3 (de) 1991-12-23 1992-12-22 Sicherheitsspritze
EP93901899A Withdrawn EP0618818A4 (de) 1991-12-23 1992-12-22 Sicherheitsspritze.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP98105451A Withdrawn EP0914837A3 (de) 1991-12-23 1992-12-22 Sicherheitsspritze

Country Status (5)

Country Link
US (1) US5211629A (de)
EP (2) EP0914837A3 (de)
JP (1) JP3486189B2 (de)
CA (1) CA2126440A1 (de)
WO (1) WO1993012829A1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
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US6724114B2 (en) 2001-12-28 2004-04-20 Emerson Electric Co. Doubly salient machine with angled permanent magnets in stator teeth

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EP0914837A3 (de) 1999-06-02
EP0618818A4 (de) 1995-05-24
US5211629A (en) 1993-05-18
EP0914837A2 (de) 1999-05-12
JPH07506011A (ja) 1995-07-06
CA2126440A1 (en) 1993-07-08
WO1993012829A1 (en) 1993-07-08
JP3486189B2 (ja) 2004-01-13

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